Premenstrual SyndromeNCT06665347
Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome
A study testing Progressive muscle relaxation and Yoga in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Progressive muscle relaxation and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages will be ranged from 18 to 25 years old.
- Their body mass index (BMI) will be less than 30 kg/m².
- They will be virgin.
- They will have regular menstrual cycles.
- They will suffer from Premenstrual syndrome based on daily record of severity of problems.
- All women will be conscious and free from any medical disease.
Who cannot join
- Women with the following criteria should be excluded from this study:
- Women with endocrine disturbance.
- Endometriosis.
- Pelvic inflammatory disease.
- Any pelvic pathology conditions.
- Women had hysterectomy or ovariectomy.
- Women use medications as contraceptive pills, pain relief drugs and antidepressant drugs.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome.
Read the detailed description
Premenstrual syndrome (PMS) is characterized by a collection of physical, emotional, psychological, and behavioral symptoms that appear in a cyclic and recurring pattern during the late luteal phase of the menstrual cycle and alleviate within two to four days of menstruation.
Premenstrual Syndrome has a negative impact on young girls' lives, which can lead to reduced work efficiency and quality of work, increased accidents and lack of school attendance. Therefore, there is a need to develop treatment protocols for coping with premenstrual symptoms.
Yoga denotes union and integration and improves biopsychosocial and spiritual wellness. In other words, yoga is a form of mind-body health that combines physical activity with inner-directed mindfulness to achieve self-consciousness through breathing and meditation.
So, this study will be conducted to contribute and add new information that may help the field of physical therapy. It will provide an evidence base for the efficacy of yoga on management of psychological aspect and quality of life in premenstrual syndrome, owing to its low cost, and ease use that may lead to improvement of symptoms.
- Conditions
- Premenstrual Syndrome
- Being tested
- Progressive muscle relaxation, Yoga
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxationOther
The participants will receive progressive muscle relaxation for 8 weeks. The muscles of the hand, arm, face, shoulder and neck, chest, abdomen, back, thigh and hip, legs and feet will be contracted and relaxed in sequence. The contraction time is 5 seconds (s), and the relaxation time is 10s.
YogaOther
The participants will receive yoga for 30 minutes/session, 3 sessions/week for 8 weeks. The session will begin with 5 minutes for warming up. Twenty minutes of wind relieving position (pavanmuktasana), corpse position (savasana), standing side stretch position, seated forward bend (paschimothanasana), cobra position (bhujangasana), and chair position (utkatasana). Five minutes of cooling down.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation group | Active comparator | All participants in this group will receive progressive muscle relaxation for 8 weeks Receives: Other: Progressive muscle relaxation |
| Progressive muscle relaxation and Yoga group | Experimental | All participants in this group will receive the same progressive muscle relaxation plus yoga for 8 weeks. Receives: Other: Progressive muscle relaxation; Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of premenstrual symptoms
It will be assessed using daily record of severity of problems (DRSP). It was used to capture premenstrual symptoms. DRSP contained two parts: symptoms related to menstruation (21 items) and their impairment in daily life (3 items). The symptoms included depression, hopelessness, feelings of worthlessness, increased sleeping, trouble sleeping, feeling overwhelmed, breast tenderness, breast swelling, headache, joint or muscle pain, anger, conflicts or problems with people, anxiety, mood swings, sensitivity to rejection, decreased interest, difficulty concentrating, fatigue, increased appetite, craving specific foods, and feeling out of control All items were rated from 1 ("not at all") to 6 ("extreme"). The higher the score, the more severe the premenstrual symptoms.
Measured: 8 weeks
Assessment of anxiety
The spielberger state trait anxiety inventory will be used to assess anxiety for all participants. It is a 40-item self-report measure of anxiety using a 4-point Likert-type scale for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. its score is ranged from 20-80 on both its two subscales.
from 20-37 means no or low anxiety, 38-44 means moderate anxiety and 45-80 means severe anxiety.
Measured: 8 weeks
Assessment of depression:
It will be assessed using Beck depression inventory. It is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. its score is ranged from 0-63 and the lowest is zero.
Measured: 8 weeks
Assessment of Quality of life
the SF-36 questionnaire will be used to assess quality of life for all participants. It consists of 36 questions. The SF-36 assesses eight dimensions that include: physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. the score is ranged from 0-100. 1 is for the worse health and 100 for the ideal health.
Measured: 8 weeks
Assessment of stress level
A blood sample will be taken from each woman in the two groups at pre-treatment and post-treatment to measure cortisol levels at 8 AM before breakfast for all cases. it will be used as an objective indication of pain level. its normal values are 5 to 25 mcg/dl or 140-690 nmol/L.
Measured: 8 weeks
Assessment of pain intensity
It will be assessed using the visual analogue scale (VAS). VAS is a simple and frequently used method for the assessment of variations in intensity of pain. In clinical practice the percentage of pain relief, assessed by VAS, is often considered as a measure of the efficacy of treatment. the scale ranges from 0 to 10 with 0 meaning no pain and 10 meaning severe pain
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start2 Nov 2024
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Mohamed Abd El-Wahab, Cairo University
- Investigators
- Hossam Al Din Kamel, Professor, Study director, Al-Azhar Universitykhadyga Abdul Aziz, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665347
- Sponsor's protocol ID
- P.T.REC/012/004757
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06665347
- Acronym / sponsor ID
- P.T.REC/012/004757
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome.
Detailed description
Premenstrual syndrome (PMS) is characterized by a collection of physical, emotional, psychological, and behavioral symptoms that appear in a cyclic and recurring pattern during the late luteal phase of the menstrual cycle and alleviate within two to four days of menstruation.
Premenstrual Syndrome has a negative impact on young girls' lives, which can lead to reduced work efficiency and quality of work, increased accidents and lack of school attendance. Therefore, there is a need to develop treatment protocols for coping with premenstrual symptoms.
Yoga denotes union and integration and improves biopsychosocial and spiritual wellness. In other words, yoga is a form of mind-body health that combines physical activity with inner-directed mindfulness to achieve self-consciousness through breathing and meditation.
So, this study will be conducted to contribute and add new information that may help the field of physical therapy. It will provide an evidence base for the efficacy of yoga on management of psychological aspect and quality of life in premenstrual syndrome, owing to its low cost, and ease use that may lead to improvement of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation group | Active comparator | Other: Progressive muscle relaxationAll participants in this group will receive progressive muscle relaxation for 8 weeks |
| Progressive muscle relaxation and Yoga group | Experimental | Other: Progressive muscle relaxation, Other: YogaAll participants in this group will receive the same progressive muscle relaxation plus yoga for 8 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Their ages will be ranged from 18 to 25 years old.
- Their body mass index (BMI) will be less than 30 kg/m².
- They will be virgin.
- They will have regular menstrual cycles.
- They will suffer from Premenstrual syndrome based on daily record of severity of problems.
Key exclusion criteria (7 listed)
- Women with the following criteria should be excluded from this study:
- Women with endocrine disturbance.
- Endometriosis.
- Pelvic inflammatory disease.
- Any pelvic pathology conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxationThe participants will receive progressive muscle relaxation for 8 weeks. The muscles of the hand, arm, face, shoulder and neck, chest, abdomen, back, thigh and hip, legs and feet will be contracted and relaxed in sequence. The contraction time is 5 seconds (s), and the relaxation time is 10s. | Other | Progressive muscle relaxation and Yoga group, Progressive muscle relaxation group |
| YogaThe participants will receive yoga for 30 minutes/session, 3 sessions/week for 8 weeks. The session will begin with 5 minutes for warming up. Twenty minutes of wind relieving position (pavanmuktasana), corpse position (savasana), standing side stretch position, seated forward bend (paschimothanasana), cobra position (bhujangasana), and chair position (utkatasana). Five minutes of cooling down. | Other | Progressive muscle relaxation and Yoga group |
Primary outcome
Assessment of premenstrual symptoms
Time frame: 8 weeks
It will be assessed using daily record of severity of problems (DRSP). It was used to capture premenstrual symptoms. DRSP contained two parts: symptoms related to menstruation (21 items) and their impairment in daily life (3 items). The symptoms included depression, hopelessness, feelings of worthlessness, increased sleeping, trouble sleeping, feeling overwhelmed, breast tenderness, breast swelling, headache, joint or muscle pain, anger, conflicts or problems with people, anxiety, mood swings, sensitivity to rejection, decreased interest, difficulty concentrating, fatigue, increased appetite, craving specific foods, and feeling out of control All items were rated from 1 ("not at all") to 6 ("extreme"). The higher the score, the more severe the premenstrual symptoms.
Assessment of anxiety
Time frame: 8 weeks
The spielberger state trait anxiety inventory will be used to assess anxiety for all participants. It is a 40-item self-report measure of anxiety using a 4-point Likert-type scale for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. its score is ranged from 20-80 on both its two subscales. from 20-37 means no or low anxiety, 38-44 means moderate anxiety and 45-80 means severe anxiety.
Assessment of depression:
Time frame: 8 weeks
It will be assessed using Beck depression inventory. It is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. its score is ranged from 0-63 and the lowest is zero.
Assessment of Quality of life
Time frame: 8 weeks
the SF-36 questionnaire will be used to assess quality of life for all participants. It consists of 36 questions. The SF-36 assesses eight dimensions that include: physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. the score is ranged from 0-100. 1 is for the worse health and 100 for the ideal health.
Assessment of stress level
Time frame: 8 weeks
A blood sample will be taken from each woman in the two groups at pre-treatment and post-treatment to measure cortisol levels at 8 AM before breakfast for all cases. it will be used as an objective indication of pain level. its normal values are 5 to 25 mcg/dl or 140-690 nmol/L.
Assessment of pain intensity
Time frame: 8 weeks
It will be assessed using the visual analogue scale (VAS). VAS is a simple and frequently used method for the assessment of variations in intensity of pain. In clinical practice the percentage of pain relief, assessed by VAS, is often considered as a measure of the efficacy of treatment. the scale ranges from 0 to 10 with 0 meaning no pain and 10 meaning severe pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam Al Din Kamel, Professor study director
Al-Azhar University
khadyga Abdul Aziz, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation and Yoga in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of premenstrual symptoms (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.